I. To evaluate partial response (PR). II. To evaluate overall response (CR+PR). III. To evaluate the safety and tolerability of the regimen. IV. To assess the 2 year event free survival (EFS) and overall survival (OS) using this regimen.

V. To assess the percentage of patients who intended to receive transplant versus those who actually proceeded with transplant.

VI. To evaluate the ability to collect peripheral blood stem cells after this regimen.

OUTLINE:

Patients receive cyclophosphamide intravenously (IV) and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or orally (PO) once daily (QD) on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.

After completion of study treatment, patients are followed up for 2 years (transplant patients) or periodically.

- Pathology material (hematoxylin and eosin [H&E] stain, immunohistochemistry [IHC] and pathology report from initial diagnosis, if slides are not available, then 8 unstained slides of 4 micron thickness or a representative block should be sent) will be reviewed, and the diagnosis confirmed by University Nebraska Medical Center (UNMC) pathology department (retrospective diagnostic review: treatment may commence prior to the UNMC review)

- No prior therapy with the exception of prior radiation therapy and 1 cycle of chemotherapy based on current diagnosis and clinical condition

- Age 19 years or older (the age of consent in Nebraska); age 18 years or older (applicable to states where the age of majority is 18)

- Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x ULN unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range

- Patients with measurable disease; patients with non-measurable but evaluable disease may be eligible after discussion with the principal investigator (PI); baseline measurements and evaluations must be obtained within 6 weeks of registration to the study; abnormal positron emission tomography (PET) scans will not constitute evaluable disease, unless verified by computed tomography (CT) scan or other appropriate imaging

- Patients with measurable disease must have at least one objective measurable disease parameter; a clearly defined, bidimensionally measurable defect or mass measuring at least 2 cm in diameter on a CT scan will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy

- Women must not be pregnant or breast-feeding due to teratogenic effects of chemotherapy

- All females of childbearing potential must have a blood test within 2 weeks prior to registration to rule out pregnancy

- Pregnancy testing is not required for post-menopausal or surgically sterilized women

- Patient must be able to adhere to the study visit schedule and other protocol requirements

- Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care; with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

- No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study

- Prior malignancies within the past 3 years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen (PSA) levels

- Patients with a diagnosis of other peripheral T-cell lymphoma (PTCL) histologies other than those specified in the inclusion criteria

- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment

- Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

- Concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and trimethoprim/sulfamethoxazole will not be allowed, since these may result in delayed clearance of pralatrexate

Type of Study:

Interventional

Study Design:

Outcome Measure:

CR rate of CEOP and P treatment

Outcome Description:

Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete course of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals. A CR rate > 50% would be promising if the toxicity profile is acceptable.

Outcome Time Frame:

Up to 6 courses

Safety Issue:

No

Principal Investigator

Julie Vose

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Food and Drug Administration

Study ID:

569-10

NCT ID:

NCT01336933

Start Date:

July 2011

Completion Date:

Related Keywords:

Anaplastic Large Cell Lymphoma

Angioimmunoblastic T-cell Lymphoma

Hepatosplenic T-cell Lymphoma

Peripheral T-cell Lymphoma

Immunoblastic Lymphadenopathy

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Non-Hodgkin

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Large-Cell, Anaplastic

Name

Location

Mayo Clinic

Rochester, Minnesota 55905

Stanford University

Stanford, California 94305

Emory University School of Medicine

Atlanta, Georgia 30322

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

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